Regional Regulatory Data Compliance Manager optimizing regulatory data processes for GSK. Collaborating with teams to enhance compliance and inspection readiness of regulatory activities.
About the role
- Providing regulatory support and guidance for global and US device product registrations at ICU Medical. Assuring compliance and assisting in registration strategies and document maintenance.
Responsibilities
- Provides regulatory support and guidance associated with global and US registration of device products, including analysis of the requirements and tracking of deliverables.
- With oversight, supports execution of global regulatory strategies and assists in creation and maintenance of global registration dossiers.
- Assures full regulatory compliance of all documentation for submissions and change management.
- Drives projects forward and executes agreed upon strategies and plans with oversight. Maintains awareness of applicable regulations.
- Plans and organizes registration packages for device products. Prepares registration packages in line with local regulatory requirements and guidelines.
- With oversight, understand and respond to regulatory agency correspondence.
- Evaluates manufacturing and labeling changes for regulatory impact. Accurately describes these changes for ease of regulatory agency review.
- Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review.
- Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions.
Requirements
- Bachelor’s Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
- RAC Certification preferred
- A minimum of two years of experience in Medical Products Industry in Regulatory Affairs.
- Able to assess scientific arguments and apply analytical and logical reasonings.
- Ability to effectively prioritize workload and multitask with minimal supervision.
- Good interpersonal skills.
- Good oral and written communications skills.
- Demonstrated project management skills.
- Demonstrated critical thinking, contingency planning and negotiating skills.
- Understanding of regulatory and business needs with ability to engage cross functional team members.
- Must be at least 18 years of age
Benefits
- Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan
- A wide range of benefit options at affordable rates
- Additional perks to assist employees with their work-life effectiveness, such as Paid Time Off, Company Holidays, and Tuition Reimbursement
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Lead regulatory strategy for precision medicine and digital health at GSK. Collaborate with teams to ensure compliant development across multiple regions including USA and UK.
Compliance Officer responsible for day - to - day compliance activities for Aviso's Correspondent Partners business line. Monitoring trading activities and managing compliance projects.
Trade Compliance Operations Analyst responsible for compliance projects and verification of import documentation. Supporting operational functions to adhere to trade compliance policies and procedures.
Onboarding & Compliance Specialist ensuring new hires complete pre - employment requirements at WFS. Acting as the liaison between WFS and Airport Authority for badging and background checks.
Sr. Director, Regulatory Compliance at Medline overseeing quality and compliance for medical products. Leading strategic planning and management of Regulatory - Quality - Laboratory teams.
Manager en compliance et contrôle des exportations au sein d'Expleo, assurant la conformité des opérations et la protection des valeurs du Groupe. Présence à Paris avec interactions globales.
Manager for Deloitte Luxembourg's VAT Compliance department overseeing high - quality compliance services for international clients. Leading client interactions and supporting junior staff development.
Compliance Intern involved in monitoring medicine inventory and supporting clinic roles. Responsibilities include documentation, compliance checks, and data organization.